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FDA Warns Cipla Over Cross-Contamination Concerns

Posted 17 March 2020 | By Zachary Brennan 

FDA Warns Cipla Over Cross-Contamination Concerns

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to sent to a Goa, India-based manufacturing site of pharmaceutical company Cipla.

Following a more than week-long inspection last September, FDA uncovered cross-contamination of products, noting, “Your testing confirmed the presence of active ingredients from a previous product in batches of the next product.”

And the firm’s “lack of a clear root cause casts doubt on whether you have fully resolved a serious cross-contamination problem,” FDA said. The agency acknowledged that the site has suspended production in several sterile units.

The firm also failed to adequately investigate “excessive and atypical High Efficiency Particulate Air (HEPA) filters failures in a short period. More than 45 filters failed due to side leakages and media failures,” FDA said. The failures impacted about 80 batches of pharmaceuticals intended for the US market, the letter says.

In resolving the issues identified, FDA called on Cipla to provide, for the seven products that were found contaminated with traces of other active ingredients, “details of at least the 30 prior batches manufactured in all non-dedicated equipment. Include the name of the product, stage of processing, all equipment identifications, and dates of manufacture.”

FDA also called for other measures to resolve concerns raised in the Form 483 from last year.

Windlas Healthcare Private Limited

FDA on Tuesday also released a warning letter for Dehradun, India-based pharmaceutical manufacturer Windlas Healthcare, which was placed on import alert in January, as the firm “did not maintain complete and accurate data from all laboratory testing.”

FDA found that on 19 May 2018, the site’s peak detection function was “disabled multiple times during the gas chromatography (GC) residual solvent testing” of a batch of incoming active pharmaceutical ingredients that was used to manufacture tablets released into the US.

In response to the letter, among other requirements, FDA is seeking a retrospective, independent review of all invalidated laboratory incidents and out-of-specification (including in-process and release/stability testing) results for US products “irrespective of whether the batch was ultimately distributed in the US.”

Cipla Warning Letter 

Windlas Warning Letter

 

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